DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce the details of an oral presentation on the results of the Company’s NAV3-21 clinical study at the Society of Nuclear Medicine and Molecular Imaging (“SNMMI”) Annual Meeting in Anaheim, CA. The presentation, titled “A Phase I/Phase II Study of Intravenously (“IV”) Administered Tc99m Tilmanocept (“TCT”) to Determine Safety, Tolerability, Optimal Clinical Dose Selection, and Imaging Timepoint in Patients Clinically Diagnosed with Rheumatoid Arthritis (“RA”)" will be delivered at 12:30 PM, Sunday, June 23, 2019 by Arash Kardan, M.D. In addition, an abstract of the presentation will be published in a future edition of the Journal of Nuclear Medicine.
The NAV3-21 study enrolled subjects with active, moderate-to-severe RA, and healthy controls. Results from the completed trial demonstrate that Tc99m tilmanocept is well-tolerated with no serious adverse events, adverse drug reactions, or drug-related adverse events observed. Additionally, static planar images revealed joint-specific Tc99m tilmanocept localization in RA subjects to disease-involved joints of the shoulders, knees, hands, and feet, but no joint-specific localization in healthy control subjects, revealing potentially significant immunodiagnostic information about CD206-expressing synovial macrophage involvement in RA. An optimal imaging time window post-Tc99m tilmanocept IV administration, as well as optimal dosing, were also determined.
Navidea’s Phase 2B study, titled “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (“TUV”) on Tc 99m Tilmanocept Planar Imaging” is ongoing. Two sites are now open for recruitment and the first four patients have been enrolled into the study. It is anticipated that two more sites will be opened shortly. This study is designed to evaluate the reliability and sensitivity of assessments in both healthy controls and in subjects with active RA. The study is stratified into three arms, with the first two arms consisting of  disease-free healthy controls and  clinically diagnosed RA subjects on stable treatment. The third arm is designed to assess the efficacy of TUV global in clinically diagnosed subjects with active RA and will power the upcoming pivotal Phase 3 trial.
Michael Rosol, Chief Medical Officer for Navidea, said, “We are excited to present the results from our Phase 1/2 study demonstrating joint-specific localization to inflamed joints of RA subjects when compared to healthy controls, as well as determining the optimum clinical dose for imaging with Tc99m tilmanocept in RA.” Dr. Rosol continued, “These results have provided support to our initiative for the currently running follow-on Phase 2B, as well as our next upcoming Phase 2B and the Phase 3 study intended to garner FDA approval of new indications for Tc99m tilmanocept in RA patients. We are very pleased that enrollment of our first Phase 2B has begun and is proceeding well.”
Bonnie Abbruzzese, Navidea’s Senior Director, Clinical Research, said, “We are pleased that subject recruitment for our Phase 2B has started off at a good pace, and the entire clinical team is working hard to continue to open additional sites as well as to monitor continued subject recruitment. The study results to be presented at SNMMI laid the groundwork for this latest trial, and we are looking forward to seeing the results presented in Anaheim.”
RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population.1 If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.
For more information, please visit www.navidea.com.
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